Ignite Creation Date:
2024-05-06 @ 7:22 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05998980
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2023-08-11
Brief Title:
6-year Clinical Performance of Prefabricated and Composite Veneers Componeer
Sponsor:
Ege University
Organization:
Ege University
Study Overview
Official Title:
Clinical Comparison of Prefabricated Resin Composite Veneers and Direct Resin Composite Veneers Over 6-years
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to compare the clinical performance of composite veneers performed in two different ways indirect and direct methods over a period of 6-year
30 volunteer patients without systemic diseases and who applied to Ege University School of Dentistry for the esthetic restoration of their anterior diastema gap were selected according to inclusion and exclusion criteria The closure of 102 diastema was randomly performed with prefabricated composite resin veneers n15 indirect method- Componeer Coltène Altstätten Switzerland or direct composite resin veneers n15 direct method- Essentia GC Japan These restorations were clinically evaluated at baseline 1-2-6-year by two experienced and blind examiners according to modified Ryge criteria USPHS criteria Color match marginal discoloration anatomic form marginal adaptation secondary caries surface roughness retention and polishing retention were evaluated for that purpose Statistical analysis was performed with McNemar and Chi-square tests p005
30 volunteer patients without systemic diseases and who applied to Ege University School of Dentistry for the esthetic restoration of their anterior diastema gap were selected according to inclusion and exclusion criteria The closure of 102 diastema was randomly performed with prefabricated composite resin veneers n15 indirect method- Componeer Coltène Altstätten Switzerland or direct composite resin veneers n15 direct method- Essentia GC Japan These restorations were clinically evaluated at baseline 1-2-6-year by two experienced and blind examiners according to modified Ryge criteria USPHS criteria Color match marginal discoloration anatomic form marginal adaptation secondary caries surface roughness retention and polishing retention were evaluated for that purpose Statistical analysis was performed with McNemar and Chi-square tests p005
Detailed Description:
The aim of this study is to compare the clinical performance of composite veneers performed in two different ways indirect Componeer and direct methods Essentia over a period of 6-year
The study protocol was approved by the Ethical Committee of Ege University Izmir Turkey 16-218 01042016 30 patients without any systemic diseases 10 males 20 females mean age 34 and with aesthetic complaints on their anterior teeth were treated with 102 restorations 48 Componeer and 54 Essentia
In Group 1 48 teeth 15 patients were restored with Componeer prefabricated veneers Coltène Altstätten Switzerland in combination with Synergy D6 nanohybrid resin composite Coltène and One Coat Bond Coltène adhesive system In Group 2 54 teeth 15 patients were restored with Essentia GC Japan micro-hybrid resin composite in combination with G-Premio Bond GC adhesive system
Periodontal treatments fillings and bleaching treatments were performed if necessary before any veneer treatment For the pre-treatment records 3 photographs smile anterior occlusion and upper anterior teeth alone were taken from each patient Both groups used the Button Try technique for color selection Componeer sizing guide was used for size selection in Group 1 Then teeth were cleaned with non-fluoride pumice Cleanic Kerr Dental ABD using a polishing brush Isolation of the teeth and retraction of the lips were achieved with a rubber dam OptraDam Ivoclar Vivadent Liechtenstein Prefabricated veneers were prepared for the cementation process in Group 1 Then the labial surfaces were etched using 36 phosphoric acid for 30 s The etched surfaces were rinsed for 30 s and dried One Coat Bond Coltene adhesive system was applied on the labial surfaces of the teeth in accordance with user instructions in both groups In Group 1 Synergy D6 nano hybrid resin composite was placed on the inner surfaces of the prefabricated veneers before being applied on appropriate teeth Then the restorations were light-cured for 40 s from each surface D-Light Pro GC and polished with a polishing paste Prisma Gloss Extra Fine Dentsply NY ABD and a felt wheel
In Group 2 Essentia GC micro-hybrid resin composite with dentin color was placed on the labial surfaces of the teeth and light-cured D-Light Pro GC After that layer Essentia enamel shades were placed over the labial surface of the tooth and light-cured for 20 s from each surface The diamond bur contouring was performed and polishing discs Super-Snap Rainbow Technique Kit SHOFU were used For polishing purposes a polishing paste Prisma Gloss Extra Fine Dentsply NY ABD and a felt Wheel were used
In group 1 gingival borders were adapted with contouring and polishing discs Super-Snap Rainbow Technique Kit SHOFU Then proximal surfaces were polished using proximal sandpaper strips Occlusion was checked for premature contacts Two calibrated observers who were blinded to the objective of this study performed the evaluations Color match marginal adaptation marginal discoloration anatomic form retention secondary caries and gloss retention were the properties evaluated for the restorations at baseline 1-2-6-year using Modified Ryge Criteria USPHS Criteria Statistical analysis was performed with McNemar and Chi-square tests p005
The study protocol was approved by the Ethical Committee of Ege University Izmir Turkey 16-218 01042016 30 patients without any systemic diseases 10 males 20 females mean age 34 and with aesthetic complaints on their anterior teeth were treated with 102 restorations 48 Componeer and 54 Essentia
In Group 1 48 teeth 15 patients were restored with Componeer prefabricated veneers Coltène Altstätten Switzerland in combination with Synergy D6 nanohybrid resin composite Coltène and One Coat Bond Coltène adhesive system In Group 2 54 teeth 15 patients were restored with Essentia GC Japan micro-hybrid resin composite in combination with G-Premio Bond GC adhesive system
Periodontal treatments fillings and bleaching treatments were performed if necessary before any veneer treatment For the pre-treatment records 3 photographs smile anterior occlusion and upper anterior teeth alone were taken from each patient Both groups used the Button Try technique for color selection Componeer sizing guide was used for size selection in Group 1 Then teeth were cleaned with non-fluoride pumice Cleanic Kerr Dental ABD using a polishing brush Isolation of the teeth and retraction of the lips were achieved with a rubber dam OptraDam Ivoclar Vivadent Liechtenstein Prefabricated veneers were prepared for the cementation process in Group 1 Then the labial surfaces were etched using 36 phosphoric acid for 30 s The etched surfaces were rinsed for 30 s and dried One Coat Bond Coltene adhesive system was applied on the labial surfaces of the teeth in accordance with user instructions in both groups In Group 1 Synergy D6 nano hybrid resin composite was placed on the inner surfaces of the prefabricated veneers before being applied on appropriate teeth Then the restorations were light-cured for 40 s from each surface D-Light Pro GC and polished with a polishing paste Prisma Gloss Extra Fine Dentsply NY ABD and a felt wheel
In Group 2 Essentia GC micro-hybrid resin composite with dentin color was placed on the labial surfaces of the teeth and light-cured D-Light Pro GC After that layer Essentia enamel shades were placed over the labial surface of the tooth and light-cured for 20 s from each surface The diamond bur contouring was performed and polishing discs Super-Snap Rainbow Technique Kit SHOFU were used For polishing purposes a polishing paste Prisma Gloss Extra Fine Dentsply NY ABD and a felt Wheel were used
In group 1 gingival borders were adapted with contouring and polishing discs Super-Snap Rainbow Technique Kit SHOFU Then proximal surfaces were polished using proximal sandpaper strips Occlusion was checked for premature contacts Two calibrated observers who were blinded to the objective of this study performed the evaluations Color match marginal adaptation marginal discoloration anatomic form retention secondary caries and gloss retention were the properties evaluated for the restorations at baseline 1-2-6-year using Modified Ryge Criteria USPHS Criteria Statistical analysis was performed with McNemar and Chi-square tests p005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None